HiRes Ultra CI HiFocus SlimJ ElectrodeRecalls & reported problems across all models
Advanced Bionics AG · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 538
- Deaths reported
- 0
- Injuries reported
- 104
- Recalls
- 0
We found 3 models of HiRes Ultra CI HiFocus SlimJ Electrode by Advanced Bionics AG in the FDA's device registry (GUDID). Together they are named in 538 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2018 and Sep 21, 2026 — classified as 104 injuries, 434 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (406 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported HiRes Ultra CI HiFocus SlimJ Electrode problems
Device problems
- Mechanical Problem406
- Impedance Problem125
- Adverse Event Without Identified Device or Use Problem94
- Therapeutic or Diagnostic Output Failure36
- Output Problem30
- Appropriate Device Problem Term/Code Not Available21
- Insufficient Device Problem Information19
- Migration or Expulsion of Device18
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available371
- Failure of Implant108
- Insufficient Information96
- Therapeutic Response, Decreased31
- No Clinical Signs, Symptoms or Conditions20
- Pain16
- No Known Impact Or Consequence To Patient15
- Unspecified Infection14
HiRes Ultra CI HiFocus SlimJ Electrode models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HiRes™ Ultra CI HiFocus™ SlimJ Electrode CI-1600-05Implant, Cochlear335 reports
- HiRes™ Ultra CI HiFocus™ SlimJ Electrode CI-1600-05Implant, Cochlear178 reports
- HiRes™ Ultra CI HiFocus™ SlimJ Electrode CI-1600-05Implant, Cochlear25 reports
Recent HiRes Ultra CI HiFocus SlimJ Electrode adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Mechanical Problem
The recipient reportedly experienced decreased performance. A review of the recipient¿s test data indicated impedance issues. The recipient's device was explanted. The recipient was reimplanted with another Advanced Bionics cochlear device.
Patient problems: Insufficient Information
MAUDE report 50845839 ↗InjurySep 16, 2026Malposition of Device; Adverse Event Without Identified Device or Use Problem
The recipient reportedly underwent repositioning surgery following initial implant surgery.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 50788323 ↗MalfunctionSep 2, 2026Mechanical Problem
Patient problems: Insufficient Information
MAUDE report 50571286 ↗MalfunctionMay 21, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES. A REVIEW OF THE RECIPIENT¿S TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, AND IMPROVEMENT WAS NOTED BUT NOT FULLY RESOLVED. REVISION SURGERY IS SCHEDULED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25249946 ↗MalfunctionMay 6, 2026Mechanical Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING DECREASED PERFORMANCE. A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25104490 ↗MalfunctionApr 23, 2026Mechanical Problem
A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES, DESPITE THE DEVICE TESTING WITHIN NORMAL LIMITS. PROGRAMMING CHANGES WERE MADE. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24972566 ↗MalfunctionApr 13, 2026Mechanical Problem
A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT'S DEVICE WAS EXPLANTED AND WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.
Patient problems: Failure of Implant
MAUDE report 24866817 ↗InjuryApr 7, 2026Mechanical Problem
THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED.
Patient problems: Pain
MAUDE report 24801197 ↗MalfunctionMar 25, 2026Mechanical Problem
THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. A REVIEW OF THE RECIPIENT'S TEST DATA INDICATES IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS HAVE BEEN MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS RE-IMPLANTED WITH ANOTHER COCHLEAR DEVICE.
Patient problems: Failure of Implant
MAUDE report 24687773 ↗MalfunctionMar 17, 2026Adverse Event Without Identified Device or Use Problem; Lack of Effect
THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE, DESPITE THE DEVICE TESTING WITHIN NORMAL LIMITS. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24619767 ↗MalfunctionMar 13, 2026Mechanical Problem
A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 24594375 ↗MalfunctionMar 12, 2026Mechanical Problem; Patient Device Interaction Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES. A REVIEW OF THE TEST DATA INDICATED IMPEDANCE ISSUES. PROGRAMMING ADJUSTMENTS WERE MADE, AND THE RECIPIENT NOTED IMPROVEMENT. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 24582248 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
THE RECIPIENT WAS REPORTEDLY HOSPITALIZED DUE TO UNKNOWN REASONS. THE RECIPIENT UNDERWENT AN MRI AND PRESENTED WITH PAIN. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION, ONCE MORE INFORMATION IS OBTAINED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 24397770 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING BACTERIAL MENINGITIS. THE RECIPIENT IS PRESENTING WITH DIZZINESS, HEADACHE AND NOISE WITH AND WITHOUT DEVICE USE. THE RECIPIENT WAS PRESCRIBED CORTICOSTEROIDS AND ANTIBIOTICS (TYPE UNKNOWN) ON (B)(6) 2026. ADVANCED BIONICS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Dizziness; Headache; Meningitis
MAUDE report 24239946 ↗InjuryJan 22, 2026Migration
THE RECIPIENT REPORTEDLY EXPERIENCED FACIAL NERVE STIMULATION WITH DEVICE USE AND DECREASED PERFORMANCE. A CT SCAN CONFIRMED ELECTRODE MIGRATION. PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Undesired Nerve Stimulation
MAUDE report 24154679 ↗
Other Advanced Bionics AG products
All Advanced Bionics AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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